Singapore legislation
Regulation 16
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 16
Supply of Class 1 CTGT products
Subregulation 1
For the purposes of section 17(1) of the Act and without affecting regulation 38, a person who supplies in a series of supplies a Class 1 CTGT product in accordance with regulation 15(1)(a), (b), (c), (d), (e), (ea), (ec) or (f) must, before starting to supply that CTGT product —
give notice to the Authority in the form and manner specified on the Authority’s website of the supply of that CTGT product, and receive the Authority’s written acceptance of the notification;
provide the information to the Authority about that CTGT product that the Authority requires in the form and manner specified on the Authority’s website;
ensure, in relation to a CTGT product that is imported or obtained from a facility outside Singapore, that the facility is approved or licensed by the regulatory agency of the foreign jurisdiction, or accredited by an international accreditation body as specified by the Authority, to supply that CTGT product in that jurisdiction; and
ensure that the CTGT product is free from infectious agents.
Subregulation 2
The notice mentioned in paragraph (1)(a) must be accompanied by the relevant fee.
Subregulation 3
For the purposes of paragraph (1), a CTGT product is treated as a Class 1 CTGT product if it would have been so assigned had the CTGT product been registered.